Specimen collection and application apparatus

ABSTRACT

A device for quantitively collecting, preserving and mailing a fresh and wet specimen of fecal or other biological matter for later analysis comprises a tubular vessel defining a chamber closed at one axial end by a plug and restricted at the opposite end by a narrow aperture. A stopper for closing the open end of the vessel extends into a stick whose distal portion comprises indentations capable of retaining a portion of the biological matter when the stick is dipped into it. The distal portion of the stick is shaped and dimensioned to intimately and circumferentially contact the edge of the aperture so that the amount of matter introduced into the chamber is limited to the part having penetrated into the indentations. The shank of the stick is dimensioned to seal the aperture once the stopper has been screwed upon the open end of the vessel. The plug mounts a breakable hollow nib and is installed after introduction into the chamber of a metered volume of preserving solution. A cover caps the plug and nib to provide additional sealing of that end of the vessel during transportation.

FIELD OF THE INVENTION

This invention relates to methods and devices practiced and used in thecollection, preservation, transportation and analysis of biologicaltissues and bodies, and more specifically to instruments used forcollecting specimens of fecal matter or other similar biologicalmaterial.

BACKGROUND OF THE INVENTION

Several devices and methods have been used in the past to collect,preserve and transport and dispense biomedical specimens including fecalsamples for later analysis by a laboratory or for clinical studies. Themost common has been a smear paper pad, upon which, in the case of fecalsamples, three consecutive specimens are smeared, covered then sent foranalysis. One of the most common problems associated with this deviceand method is dehydration. Even under rehydrating condition, a fecaloccult blood test of dry samples on paper pads will give false positiveor negative results. A false positive result may trigger a relativelyexpensive colonoscopic or barium enema examination that will probably oreventually eliminate the false diagnosis. In the case of a falsenegative result, an early stage colorectal cancer may be missed, and ifthen metastosis occurs, the cancer may become incurable.

Another fecal sample collection device of the prior art comprises asimple cylindrical tube with a cap having a breakable tip and a plasticstick connected to the inside of the screw cap. The tube contains acertain amount of extraction buffer. The stick is inserted into freshfeces several times then put back into the tube and the cap is tightlysecured to seal the tube. The main advantage of this procedure is thatthe extraction buffer keeps the specimen wet and a preserving reagentmixed therewith may slow down the degradation of the biological moleculeor its markers. While this method constitutes a substantial improvementover the smear paper devices of the past, unintended breakdown of thetip on top of the cap has occurred during manipulation of mailing of thespecimen resulting in leakage and possible contamination. Moreover,specimens have a tendency to include excessive amounts of fecal materialfor the amount of preservative or reagent contained in the tuberesulting in false positive analysis. Another improved device of theprior art is disclosed in U.S. Pat. No. 6,063,038 Diamond et al. In thiscase, a filtering membrane is provided between the body of the shippingvessel which holds the specimen and a preserving/reagent solution andthe hollowed inside of the stick itself which can be accessed through aself-sealing membrane to extract a part of the liquid containing onlythe amount of specimen that passed through the filtering membrane. Thisimproved device still suffers from a high risk of spillage of thepreservative/reagent and a lack of quantitative mixing of the sample andpreserving/reagent fluid.

The instant invention results from some attempt to provide a practicalsolution to the problems and disadvantages of the aforesaid devices ofthe prior art.

SUMMARY OF THE INVENTION

The principal and secondary objects of this invention are to provide aconvenient, safe and inexpesive to manufacture device and method forcollection by a patient or unskilled person of fresh fecal or otherbiological specimens in a quantitatively metered manner and for thepreservation and leakproof shipping of the specimen through the mail toa laboratory for further analysis while avoiding degradation of thespecimen through dehydration or imbalance combination of specimen andpreserving agents.

These and other valuable objects are achieved by providing a simpletubular vessel closed at one end by a breakable hollow nib or otherreleasable sealing device that is engaged at the opposite end by a capor stopper from which a stick axially projects into the vessel. At thedistal end of the tip, a sample-holding portion has at least one radialor axial cavity and preferably indentations in the form of a spiral orhelicoidal groove. As the stopper and stick are progressively insertedinto the vessel by a screwing movement, the sample-holding portionpasses through an aperture defining a narrow channel in the center of aseptum in the median section of the vessel. The cross-section of thenon-grooved part of the sample-holding portion closely match thecross-sectional profile of the aperture so that any access specimenmatter which is not contained within an indentation, whether a cavity orgroove, is conveniently wiped out and prevented from passing into themost distal chamber of the vessel that contains a preserving fluid. Theshank of the stick right behind the sample-holding portion seals thespecimen-holding chamber so that the amount of specimen and preservingfluid are quantitatively balanced and remain so until part or all of thefluid is extracted for analysis after breaking of the sealing nib. Acover, shaped and dimensioned to safely cap the breakable nib can betightly screwed upon the closed end of the vessel to protect the nibduring manipulation and shipping of the device. The specimen-holdingchamber is thus doubly sealed at opposite ends to ensure against leakageboth before and after specimen collection. A padded shipping containermade from inexpensive disposable plastic provides a third seal andenhanced protection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional side view of a biologicalspecimen-collecting device according to the invention;

FIG. 2 is a diagrammatic cross-sectional side view of the device of FIG.1 having a

FIG. 3 is a partial cross-sectional side view of an alternate embodimentof a biological specimen-collecting device carried within a paddedmailing container according to the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION

Referring now to the drawing, there is shown a device 1 speciallyadapted to collect a specimen of fecal or other biological matter, storeand preserve it while it is mailed to a laboratory for analysis. Thedevice comprises a tubular, preferably cylindrical, vessel 2 having afirst end 3 closed and defining an access port 4 which is releasablysealed by a hollow nib 5 that can be easily broken to open the accessport and allow convenient dispensing. The opposite, normally open, end 6of the vessel is engaged by a stopper 7 comprising a knob 8 and athreaded plunger 9. Screw threads 10 matingly cooperating with thethreaded plunger are provided along the inside wall of the vessel fromthe second end 6 down to a median portion 11 of the vessel. A stick 12projects axially from the stopper, more specifically, from the conicaldistal end 13 of the plunger into the vessel. The stick comprises ashank 14 and a sample-holding distal portion 15. The sample-holdingportion consists an oblong cylindrical member into which indentations 16in the form of an helicoidal groove have been cut. The radius of thedistal portion is substantially the same as the radius of thecylindrical shank 14.

A conical transversal septum 17 in the median portion 11 of the vesseldivides the vessel into a first chamber 18 sealed by the closed end 3and a second chamber 19 accessible through the second end 6. An apertureor passageway 20 in the middle of the septum is axially lined up withthe stick 12 and has a cross-sectional geometry substantiallysymmetrical with that of the stick, that is a radius substantially equalto the radius of the shank 14 and sample-holding portion 15. Thecooperatively conically shaped distal end 13 of the plunger and septum17 allow for enahnced resiliency, thereby providing a positive seal overa larger range of plunger positions.

When the knob 8 of the stopper is turned clockwise, the sample-holdingportion 15 of the stick progressively translates from the second chamber19 into the first chamber 18 through the passageway constituted by theaperture 20 until such time as a distal part of the shank 14 engages andseals the aperture as shown in dotted line on the drawing.

A cover 21 shaped and dimensioned to cap the closed first end 3 andend-breakable nib 5 has a threaded inner wall section 22 that cooperateswith a correspondingly threaded area 23 on the outer wall of the vesselto secure the cover and thus, protect the breakable nib 5.

The end section 24 that mounts the breakable nib 5 at the first end 3 ofthe vessel is not molded integrally with the wall of the vessel, butconstitutes a separate plug which is installed only after the firstchamber 18 has been filled with the preserving fluid 25. The end section24 is preferably permanently bonded to the vessel with an adhesive. Itshould be noted that this bonding of the end section and the cover 21that further occludes both the access port 4 controlled by the breakablenib and the one sealed by the end section plug 24, combined with thedouble seal provided by the shank 14 of the stick closing the aperture20 and the stopper 7 closing the second end 6 of the vessel assuresagainst any leakage of the preserving fluid during shipment, before andafter collection of the specimen.

The device may be used as follows. At the factory, with plunger 9 fullyor partially screwed into the second end of the vessel and the aperture20 sealed, a measured volume of preserving liquid 25 is introduced intothe first chamber through the first end 3 which is then sealed by theinstallation and bonding of the end section 24. The volume is measuredto provide the desired concentration of specimen that will eventually befound in suspension in the liquid. The device is marked about the firstend 3, such as on the cover 21, with a legend such as “For LaboratoryUse” or “Lab End”. The knob 8 or upper area of the vessel is marked withanother legend such as “Open Here”, or “Patient End”. The device is thenpackaged and distributed for use.

The collection of the specimen by the patient or an assisting individualgoes as follows. Holding the stopper 7 by the knob and after unscrewingit and separating it from the vessel, the user plunges thesample-holding portion 15 of the stick into a volume of matter to beanalyzed. The stick is then inserted back into the vessel and thestopper is screwed down until the sample-holding portion passescompletely through the aperture 20 of the septum. During this procedure,the walls of the aperture coming into intimate contact with thenon-threaded part of the sample-holding portion and shank, wipe out anyexcess material which is not held within the helicoidal groove,preventing that excess material from reaching the first chamber.Accordingly, only a quantitively metered amount of specimen matter isallowed into the first chamber. The first chamber contains the meteredvolume of preserving fluid 25, preferably a liquid which will remain incontact with the specimen matter throughout storage and transportationof the vessel until part or all of it is drained for analysis bybreaking the nib 5.

It should be noted that the preserving liquid in the first chamber couldbe safely secured initially by a breakable barrier across the aperture20 of the septum or by a resiliently self-sealing aperture. In whichcase, at the factory, the stopper would be only partially engaged intothe vessel, keeping the sample-holding portion into the second chamber.Only after collection of the specimen would the stopper be completelyscrewed into the vessel and the sample-holding portion forced throughthe septum. Instead of the end section 24, the first end of the vesselcould be closed by a diaphragm through which a self-sealing access portcan be practiced by means of a syringe or any other equivalentreleasable sealing structure.

Referring now to FIG. 2, there is shown an alternate embodiment of adevice 31 for collecting, storing and protectively transporting fecal orother similar biological matter. The device formed sililarly to theprevious embodiment has a generally cylindrical vessel 32 having agently tapering diameter. The entire vessel is loadable into a sealableshipping capsule 33 which comprises a pair of open-ended cups 34, 35matable at the open ends 36, 37 along an annular snap connector 38. Eachcup has a closed end 39, 40 having cushiion pad 41, 42 formed onto theinner surface. The capsule is preferably made from an inexpensive,durable, fluid-resistant material such as polyethanol plastic.

While the preferred embodiments of the invention have been described,modifications can be made and other embodiments may be devised withoutdeparting from the spirit of the invention and the scope of the appendedclaims.

1. A device, for quantitively collecting, preserving and mailing aspecimen of fecal or other biological matter for later analysis, whichcomprises: a tubular vessel having a first closed end defining at leastone sealed access port, a second open end opposite said first end; astopper shaped and dimensioned to close said open end; and a coverreleasably occluding said sealed access port.
 2. (Cancelled). 3.(Cancelled).
 4. (Cancelled).
 5. (Cancelled).
 6. (Cancelled). 7.(Cancelled).
 8. (Cancelled).
 9. (Cancelled).
 10. (Cancelled). 11.(Cancelled).
 12. (Cancelled).
 13. (Cancelled).
 14. (Cancelled).
 15. Thedevice of claim 1, which further comprises a transversal septum in amedian portion of said vessel, said septum dividing said vessel into afirst chamber sealed by said closed end and a second chamber accessiblethrough said second end, said septum further having an axial passagewaytherethrough defining a given cross-sectional geometry.
 16. The deviceof claim 1, which further comprises.
 17. The device of claim 1, whereinsaid sealed access port comprises an end-breakable hollow nib.
 18. Thedevice of claim 1, wherein the open end of said vessel and said stopperhave cooperating screw threads.
 19. The device of claim 1, wherein saidcover is shaped and dimensioned to cap said closed end and nib.
 20. Thedevice of claim 15, which further comprises a liquid in said firstchamber.
 21. The device of claim 15, wherein said first chamber isdoubly sealed at opposite ends.
 22. The device of claim 21, whichfurther comprises a stick projecting axially from said stopper into saidvessel extending through and sealing said passageway.
 23. The device ofclaim 22, wherein said stick comprises a sample-holding distal portion.24. The device of claim 1, which further comprises an outer mailingcapsule sized and shaped to fully enclose said vessel, stopper, andcover.
 25. The device of claim 24, wherein said capsule comprises amatable pair of open-ended cylindrical cups, wherein each of said cupscomprises a closed end and a resilient pad mounted upon an inner surfaceof said closed end.